Method of detecting and predicting ovulation and the period of fertility

ABSTRACT

A method of providing information relating to the fertility of a female mammal comprising the steps of: (i) taking multiple temperature readings from the female mammal during an extended period; (ii) identifying and disregarding temperature readings having one or more characteristics of irrelevant or faulty data; (iii) obtaining one or several representative temperature values for the extended period; (iv) repeating steps (i) to (iii) over multiple extended periods; (v) analyzing the representative temperature values obtained over multiple extended periods for one or more patterns in the representative temperature values indicative or predictive of ovulation in order to provide information relating to the fertility of the female mammal to a user, wherein the representative temperature values are not the maximum or minimum temperature readings obtained for the extended period; and related uses and apparatus.

BACKGROUND TO INVENTION Ovulation

Ovulation, the release of an oocyte from an ovary of a female animal, isan important step of female reproductive biology because it is requiredin order that the oocyte may be fertilized by male sperm.

In archetypical human females, ovulation takes place on approximatelyday 14 of the typically 28 day menstrual cycle. However, onlyapproximately 10% of women regularly ovulate on day 14 of a 28 daycycle. The cycle length and day of ovulation within a single cycle canvary between women and, usually to a lesser extent, from time to time ina single woman. Variation in the cycle length of an individual womanincludes both fluctuations from one cycle to the next and longer term“drifts” in cycle length which take place over several years and may bepart of the ageing process.

In non-human mammals, the biology of ovulation varies considerably. Someanimals, for example, dogs and cattle, conform approximately to thehuman model and exhibit a non-seasonal pattern of ovulation at regularintervals. Other animals (for example, sheep, rabbits, ferrets) requireenvironmental cues, for example changing day length or the presence ofmales, in order for ovulation to be triggered. Other animals, forexample mice, only ovulate in response to copulation. There are manycircumstances, both in the fields of medicine and veterinary practice,where it is useful to know if ovulation has taken place.

In general terms, the ability to detect the presence or absence ofovulation is useful both in the diagnoses of disorders of ovulation andin providing information about likely fertility which can be used tochoose suitable timing of sexual intercourse in order to increase ordecrease the odds of pregnancy resulting in accordance with the wishesof the woman, in the field of human medicine, or in accordance with thewishes of the farmer or veterinarian in the field of animal husbandry.Furthermore, information about the timing of ovulation may be used tochoose suitable timing of fertility treatments such as intra-uterineinsemination (IUI), artificial insemination or removal of ova for invitro fertilisation

It has been estimated that one in six human couples have an unwanteddelay in conception (Taylor (2003) BMJ 327:434-436). Most of thosecouples do not have absolute infertility (that is, no chance ofconception) but rather subfertility with a reduced chance of conceptionbecause of one or more factors in either or both partners.

As part of the diagnoses of subfertility one of the key questions whichthe clinician asks is ‘does the woman ovulate?’ In addition to answeringthe above question, knowing or predicting when the woman ovulates isalso useful in cases of subfertility because it allows the couple and/orthe physician involved in providing fertility enhancement treatment totime their sexual intercourse and/or therapeutic intervention so as tomaximise the chances of conception.

Knowledge of the time of ovulation and thereby knowledge of a woman'sfertility can also be useful where a woman in a sexual relationshipwishes to avoid conception. By limiting unprotected sex to times whenthe woman is unlikely to be fertile, unwanted pregnancies can beavoided. Such a ‘natural’ method of contraception may be especiallyattractive to couples who have medical, religious or other reasons foravoiding the use of alternative contraception.

In the veterinary fields, animal sub-fertility may be a problem,particularly if the animals in question are commercially valuable (forexample race horses, cattle, companion animals) or members of anendangered species. Additionally in many animal species stud fees and/orsemen samples for artificial insemination are costly. There is thereforea need to limit those interventions to times when the female is fertile.

The Human Ovulatory Cycle

The cyclic changes in ovarian activity are controlled by the secretionof two hormones by the pituitary gland, follicle stimulating hormone(FSH) and luteinizing hormone (LH) under the control of thehypothalamus.

During the second half of the preceding cycles, high levels ofoestradiol (oestrogen) and progesterone (progestogen) act via thehypothalamus to suppress FSH and LH production by the pituitary gland.At the end of the proceeding cycle a decrease in production ofoestradiol and progesterone by the corpus luteum removes suppression ofthe hypothalamus and FSH levels start to rise. Once a threshold is met,FSH stimulates a group of ovarian follicles into growth.

The dominant follicle continues to grow towards ovulation and as it doesso it produces increasing amounts of oestradiol. This leads to a fall inFSH which removes support for non-dominant follicles and increases thedominant follicle's receptivity to LH. The high oestradiol level causesthe pituitary gland to release a large surge of LH. This peak of LHtriggers the rupture of the follicle and release of the oocyte(ovulation) approximately 37 hours after the beginning of the surge ofLH or approximately 17 hours after its peak.

The remains of the ruptured follicle become the corpus luteum whichproduces progesterone which causes an abrupt change in thecharacteristics of the cervical mucus so as to make it impenetrable tosperm. A decrease in progesterone towards the end of the cycle causesthe bleeding of menstruation.

Related changes in hormone levels are seen in veterinary species, thelevels and timing of events altering from species to species—all resultin a corresponding release of an ovum into the fallopian tube followingrupture of a mature follicle.

By convention the human ovulatory cycle (also known as the menstrualcycle) is considered to start from the first day of menses (day 1) andcontinues until the first day of menses of the following cycle takesplace.

Detection of Ovulation

The UK Royal College of Obstetricians & Gynaecologists guidelines forinvestigating whether ovulation is likely to take place includeschecking mid-luteal phase progesterone 7 days before expected menses.Other investigations which may be carried out include measuring LH, FSHand oestradiol concentrations in early follicular phase (days 2 to 6),(Taylor (2003) BMJ 327:494-497).

Measurement of hormone levels typically requires the drawing of a bloodsample or the use of urine tests. These methods of measurement have thedrawback that they require medical intervention and that each individualtest costs money.

Urine tests additionally suffer from poor reliability because urineproduction rates are subject to unpredictable variations that lead tovariations in hormone concentrations in the urine in the bladder.

Whilst blood tests may be highly suitable for occasional diagnostictesting, they have significant drawbacks if they are to be used for longperiods of time. Several surrogate markers of ovulation in human femalethat are more suitable for home use and for sustained monitoring havebeen identified. The first of these involves the woman checking theconsistency of her cervical mucus. The second involves the womanrecording her body temperature.

Body temperature is a widely used surrogate marker for the detection ofovulation. It is known that the LH peak which occurs just beforeovulation causes a rise in body temperature, (see David M E & Fugo(1948), The cause of physiologic basal temperature changes in womenClin. Endocrinol. 8:550-563 and Coyne et al., (2000)) Circadian rhythmchanges in core temperature over the menstrual cycle: method fornon-invasive monitoring, A. L. C J. Physiol. Regulatory IntegrativeComp. Physiol. 279:1316-1320. The detection of that rise is used widelyas a surrogate marker for ovulation.

The oestradiol rise before ovulation causes a slight and broad dip inbody temperature before the LH-associated rise, (David & Fugo ibid) Thisdip is not currently used as a marker of ovulation because it isdifficult to measure accurately, mainly because it is of low magnitude.

Temperature readings are typically taken once a day under the tonguewith a standard mercury, spirit or electronic medical thermometer,although temperature may also be measured on the skin surface, under thearmpit, in the ear or at any other suitable site. WO 03/078949 disclosesa retrievable indwelling thermometer which may be used to measure rectalor intravaginal temperature over an extended period of time.

Current methods of taking and analysing temperature measurements inorder to predict or detect ovulation have several drawbacks.Infrequently-taken temperatures may not be representative of the truebasal body temperature and using a thermometer to take multipletemperatures manually is time consuming and inconvenient.

The device of WO 03/078949 may be used to take multiple temperaturereadings over a time period, but nevertheless the temperatures taken maybe unrepresentative of the true basal body temperature for a number ofreasons including the time-lag required for the temperature readingdevice to warm up after initial insertion, and non-relevant temperaturechanges which come about due to inadvertent or deliberate removal,urination and diurnal temperature variations. Such inaccuracies intemperature readings cause inaccuracies in the detection of theLH-associated temperature peak and prevent the detection of theoestradiol-associated temperature dip.

DE 3342251 speculates about a device for measuring the temperature in afemale in order to detect temperature changes associated with ovulation.It is suggested that prediction of the timing of ovulation in thesubsequent cycle may be carried out by counting forward in time from thestart of the previously detected ovulatory cycle. The device disclosedin DE 3342251 measures multiple temperatures over at least part ofseveral days. The specification does not disclose any real data (forexample the data shown in the figure is obviously contrived). It issuggested that in order to minimise the effects of fluctuations intemperature that are irrelevant to detecting ovulation, maxima and/orminima curves be calculated and analysed for the presence of temperaturechanges indicative of ovulation. The Inventors of the present inventionconsider that the use of maxima or minima curves as disclosed in DE3342251 is unlikely to work well because those variables are highlysusceptible to irrelevant temperature changes (outlier data values).

GB 2077593 is directed mainly to monitoring the body temperatures ofcows rather than humans. In fact page 3, column 1, lines 62 to 65suggests that reliable detection of ovulation in humans by temperaturemeasurement cannot be carried out. In terms of processing of temperaturereadings it is taught that temperature may be used for the detection ofoestrus and for the detection of fever associated with poor health. Itis also taught that a cow's temperature is partially dependent onambient conditions and on individual characteristics of a particularcow. The recording of long term temperature readings in a cow is carriedout in order to solve a different problem to that of detection ofovulation in humans. Whereas human women change temperature during theircycle, they exhibit similar temperatures from cycle to cycle. This isnot the case in cattle. The reason for recording temperatures presentedin GB 2077593 is in order to establish a temperature baseline for asingle animal for a single cycle from which temperature changesassociated with oestrus may be detected. The examples of GB 2077593 showa single reading being taken every day. The temperatures are measuredelectronically and transmitted by telemetry, but there is no disclosureof computer processing of the data. Presumably the farmer is presentedwith a set of data for his herd every day and makes his own assessmentof them in order to determine which of his cows are in oestrus that day.

EP0424102 discloses a device which provides an indication of temperatureand time of ovulation and of predicted periods of fertility. Analgorithm for obtaining a steady reading is disclosed which would appearto be similar to that used in standard digital medical thermometers, butthere is no disclosure of obtaining multiple temperature readings overan extended period and then discarding those that are spurious and thosethat are genuine but associated with events irrelevant to ovulation.

The present invention meets a number of objectives. These include (butare not limited to), the detection of ovulation (or the absence ofovulation) as an aid in diagnosing infertility or subfertility; theprediction of ovulation as an aid to determining time periods offertility in order to increase or decrease chances of conception; andthe monitoring of medical interventions intended to assist conception inorder to improve their success rates and/or reduce the risks of unwantedside effects.

BRIEF DESCRIPTION OF INVENTION

The invention provides a method of providing information relevant to thefertility of a female mammal comprising the steps of:

-   1) taking multiple temperature readings from the female mammal    during an extended time period;-   2) identifying and disregarding temperature readings having one or    more characteristics of irrelevant or faulty data;-   3) obtaining one or several representative temperature values for    the extended time period;-   4) repeating steps 1) to 3) over multiple extended periods;-   5) analysing the representative temperature values obtained over    multiple extended periods in order to identify a pattern in the    representative temperature values indicative or predictive of    ovulation in order to provide information relevant to the fertility    of the female mammal to a user.

The invention also provides use of a method of the invention as an aidto diagnosis of anovulation or the diagnosis of irregular ovulation oras an aid to the diagnosis of subfertility or infertility or an aid toconception (including as an aid to assisted conception), or as acontraceptive method.

The invention also provides a device for providing information relevantto the fertility of a female mammal comprising:

-   -   a temperature measuring device for taking multiple body        temperature readings from the female mammal during multiple        extended periods;    -   a memory for storing said temperature readings;    -   a processor for identifying temperature readings having one or        more characteristics of irrelevant or faulty data and either        deleting said readings or labelling them to be subsequently        disregarded; and for obtaining one or several representative        temperature values for each extended period; and for analysing        the representative temperature values obtained over multiple        extended periods for one or more patterns in the representative        temperature values indicative or predictive of ovulation; and    -   a signalling device to provide information relevant to the        fertility of the female mammal to a user.

The invention also provides a user terminal comprising:

-   -   a temperature measuring device for taking multiple body        temperature readings from a female mammal during multiple        extended periods;    -   a memory for storing said temperature readings;    -   a means for communicating the multiple body temperature readings        or a derivative thereof, stored in the memory to a remote data        processing device;    -   means for receiving information relevant to the fertility of the        female mammal from a remote computer file server;    -   a signalling device to provide said information relevant to the        fertility of the female mammal to a user.

The invention also provides a remote data processing device comprising:

-   -   means for receiving multiple body temperature readings of a        female animal or a derivative thereof from a user terminal;    -   a processor for identifying temperature readings having one or        more characteristics of faulty or irrelevant data and either        deleting said readings or labelling them to be subsequently        disregarded; and for obtaining one or several representative        temperature values for each extended period; and for analysing        the representative temperature values obtained over multiple        extended periods for one or more patterns in the representative        temperature values indicative or predictive of ovulation and        thereby provide information relevant to the fertility of the        female mammal to a computer file server for later retrieval by a        user.

The invention also provides a remote computer file server holdinginformation relevant to the fertility of multiple female mammals, theinformation relating to each female mammal being labelled with a uniqueidentifier code corresponding to an individual female mammal, said fileserver being arranged to provide to a user, the information labelledwith a particular unique identifier code in response to the provision ofthat code to the remote computer file server.

BRIEF DESCRIPTION OF FIGURE

FIG. 1 illustrates a device and its use according to one embodiment ofthe invention.

FIG. 2 shows real data obtained from an indwelling thermometer worn by ahuman female for two consecutive days (10 June as line A and 11 June asline B) The x-axis shows the time of day or night and the bar C belowthe temperature plots shows when the woman was awake or asleep.

FIG. 3 shows real data obtained from a woman over her complete ovulatorycycle (except for days 0 to 8 during which menstruation took place).Said data has been processed in various ways before being presented inthe figure.

FIG. 4 shows real data obtained from a woman over her complete ovulatorycycle (except for a few days when menstruation took place and a furthertwo days where temperatures were not recorded). During each overnightperiod temperature was recorded and is shown in the figure. The shortgaps between the overnight temperatures represent the daytime periodduring which temperature readings were not taken.

DETAILED DESCRIPTION OF INVENTION

The invention provides a method of providing information relevant to thefertility of a female mammal comprising the steps of:

-   -   i) taking multiple temperature readings from the female mammal        during an extended period;    -   ii) identifying and disregarding temperature readings having one        or more characteristics of faulty or irrelevant data;    -   iii) obtaining one or several representative temperature values        for the extended period;    -   iv) repeating steps (i) to (iii) over multiple extended periods        and over multiple ovulatory cycles;    -   v) analysing the representative temperature values obtained over        multiple extended periods and ovulatory cycles for one or more        patterns in the representative temperature values indicative or        predictive of ovulation in order to provide information about        fertility of the female mammal to a user.

According to certain embodiments, the method may be used to predictovulation, meaning that the method will indicate that ovulation isimminent. According to other embodiments the method may be used toindicate ovulation meaning that the method will provide an indication tothe user at approximately the same time as ovulation takes place.

According to certain embodiments the method may be used to detectovulation, anovulation or irregular ovulation in order to provideinformation of relevance to the diagnosis of fertility, subfertility orinfertility.

The information relevant to the fertility of the female mammal may beinformation identifying the timing of ovulation. Such information mayinclude information identifying the timing of ovulation events that havealready taken place and/or information predicting the likely timing offuture ovulation events.

According to certain embodiments the indication to the user is providedto a computer file server or other archive for later retrieval by auser.

According to certain embodiments the method provides an indication tothe user a few days (for example 1 to 6 days or 4 days) before ovulationto give sufficient warning of the fertile time period to allowintercourse to take place before the female cycle reaches the stagewhere progesterone causes the characteristics of the cervical mucus tochange so as to make it impenetrable to sperm. It should be noted inthis regard that sperm is able to survive in the female reproductivetract for several days and that sperm may take a few days to swim to theoocyte and so the best time for intercourse (or artificial insemination)so as to ensure maximum fertility will be just prior to ovulation (forexample approximately 4 days before).

According to certain preferred embodiments, the method indicates to theuser, the start and end times of the next window of fertility.

Taking Multiple Temperature Readings

The methods of the invention involve taking multiple temperaturereadings from the female mammal during an extended period. The extendedperiod may be at least 1 hour long, preferably at least 2 hours long,preferably at least 3 hours long, preferably at least 4 hours long.According to certain preferred embodiment that extended period isbetween 15 minutes and 6 hours, preferably between 1 to 6 hours, morepreferably between 2 and 5 hours, more preferably between 3 and 4 hours.According to certain embodiments the extended time period is anovernight time period. One advantage of using an overnight period isthat natural fluctuations are reduced due to the constancy of theenvironment and the relative lack of movement by the female. By“overnight time period” as used above it is intended to mean the periodduring which the female animal is asleep or expected to be asleep. Itwill be understood that for certain women (for example those employed towork at night) this time period may in fact take place during the day.Similar considerations apply to the use in nocturnal animals.

During the extended period multiple temperature readings are taken. Forexample, a reading may be taken every 20 seconds, every minute, or every5 minutes. Preferably, a reading taken every 1 to 20 minutes, morepreferably every 2 to 10 minutes, most preferably every 5 minutes.Preferably multiple temperature readings are taken at regular intervals.Preferably at least 25 temperature readings, more preferably at least50, more preferable at least 100, more preferably at least 250temperature readings are taken in the extended period. According tocertain embodiments measurements are taken every 5 to 10 minutes over aperiod of about 5 hours. According to certain preferred embodiments theextended period may extend from shortly before or shortly after thesubject goes to bed to 3, 4 or 5 hours later or until the woman wakesup, or for a particular time window during an overnight period, forexample, from 1.00 am to 5.00 am or from 12 midnight to 3.00 am.Accordingly, to certain embodiments the time period may be selected toavoid the period after about 3.00 am when a dip in temperature typicallyoccurs, although the Inventors do not report problems with takingreadings during this dip.

Identifying Faulty or Irrelevant Data

The method of the invention has as its second step the identificationand disregarding of temperature readings having one or morecharacteristics of irrelevant or faulty data.

There is a difference between faulty data and irrelevant, that is to saydata which is genuine but which is irrelevant to ovulatory cycle. Faultydata is data that does not genuinely correspond to the body temperatureof the female. It may be produced, for example, by a faulty temperaturemeasuring device or, more likely, by an intrinsic limitation of thetemperature measuring device (for example a time-lag in the response ofthe device to being placed in a body cavity). Irrelevant data is genuinedata because it genuinely reflects the body temperature of the female.However, it is caused by factors that are irrelevant to the matter ofovulation. It may be produced, for example, by diurnal temperaturefluctuations, or by changes in the ambient temperature to which thewoman is exposed.

Irrelevant or faulty data may arise from a number of sources. Forexample, data from time periods during which the user is experiencing anepisode of fever. Also, an indwelling thermometer may be removed orrepositioned if it is uncomfortable; it may be removed and washed ineither hot or cold water; its temperature may change if the femaleurinates or if body temperature changes due to changes in the externaltemperature (caused by changing weather or room heating); changes inclothing or bedding; changes in level of exertion or changes inproximity to external heat sources (for example a hot water bottle orbed partner).

Faulty data is also likely to be generated when the temperaturemeasuring device is first applied to or placed in the subject because ofthe thermal lag time required for the device to reach body temperature.Irrelevant data may also be produced when the temperature measuringdevice is not applied to or placed in the subject (for example duringperiods of non-use which may be intentional or accidental).

A method which allows irrelevant data generated when the device is notin use to be disregarded may have the additional advantage of allowingautomatic sensing of the start and end of the extended measuring period.For example if the method involves the overnight use of an indwellingtemperature measuring device, said device being stored at roomtemperature during the day, a step of disregarding irrelevant data willpermit the temperature readings generated during the day to bedisregarded and assist in the identification of separate extendedperiods each corresponding to an overnight period. This will remove theneed for manually “switching on” the device each night.

Faulty or irrelevant data may be identified by applying any suitablecharacteristic known to be associated with faulty or irrelevant data.Such characteristics include:

-   1. Temperature readings clearly out of the temperature range found    in female mammals of the species in question, for example    temperature readings above or below that expected of a female mammal    of a particular species. For example more than 2 or 3 or 4 degrees    Celsius above or below the expected body temperature of the mammal,    for example in the human more than 38° C. or less than 36° C.-   2. Temperature readings that whilst they may be within the range    expected from female mammals of the species in question are not    within the range expected for the individual in question (as    determined from historical data previously obtained from that    individual, for example temperature readings above or below that    expected of an individual female mammal). For example more than 0.5,    0.6, 0.7, 0.8, 0.9 or 1, 2 or 3 or 4 degrees Celsius above or below    the expected body temperature of the individual female mammal.-   3. Temperature readings which differ from preceding or following    values by such a degree as to indicate changes of temperature    (heating or cooling) at a rate too high to be expected to be    observed in the body temperature of a female mammal. For example    heating or cooling rates of more than 0.1° C. per minute, of more    than 0.2° C. per minute, of more than 0.3° C. per minute, of more    than 0.4° C. per minute, or more than 0.5° C. per minute, or more    than 0.6° C. per minute, of more than 0.7° C. per minute, of more    than 0.8° C. per minute or of more than 0.9° C. per minute or of    more than 1.0° C. per minute may be characteristic of faulty or    irrelevant data.-   4. Temperature readings which are clearly outliers may be    characteristic of faulty or irrelevant data. For example a single    reading or relatively few temperature readings differing    substantially from the other temperature readings collected during    the extended period are unlikely to indicate a true change in    temperature but are more likely to be indicative of faulty or    irrelevant data.-   5. Temperature readings tagged with supplementary data, for example    readings tagged by data indicating that the female was suffering    from a fever.-   6. Temperature readings obtained immediately before or immediately    after temperature readings showing any other characteristic of    faulty data. For example readings of below 36° C. may be identified    as faulty or irrelevant according to characteristic 1 above. The    readings obtained 20 minutes before and 20 minutes after such a    reading may also be identified as faulty or irrelevant.

Temperature readings having one or more characteristics of faulty dataare disregarded, meaning that they are not included in subsequent stepsof the method.

Readings which are significantly influenced by diurnal temperaturechanges may be characteristic of irrelevant data and may, according tocertain embodiments be disregarded. For example, if the temperaturereadings are taken in a human woman during overnight extended periods,the temporary core temperature dip which occurs in humans just beforewaking may be disregarded according to certain embodiments. Diurnaltemperature changes which are unconnected to levels of female hormonesand therefore unrelated to ovulation may also be observed in malemammals. Therefore temperature readings taken from female mammals thatshow similar characteristics to those observed in males of the samespecies may, optionally be regarded as characteristic of faulty orirrelevant data and be disregarded.

Readings which are identified as raised due to illness by patternrecognition algorithms may be recognised as having one or morecharacteristics of faulty or irrelevant data and be disregarded.

Readings which occur with the commencement of use, or at the end of use,of the device and which may be attributed to the device reaching a newthermal equilibrium may be recognised as having one or morecharacteristics of faulty or irrelevant data and be disregarded.

Obtaining One or Several Representative Temperature Values for theExtended Period

In order to compare and analyse temperature readings obtained fromdifferent extended periods, it is necessary to obtain one or severalrepresentative temperature values for each extended period or to obtaina comparative measurement between selected measurements within extendedperiods. For example, a comparison is made between single measurementpoints matched in time from within two or within several extendedperiods. According to certain preferred embodiments a singlerepresentative value is obtained for each extended period. According toother embodiments several representative temperature values are obtainedfor each extended period. An extended period typically lasts for severalhours. Representative temperature values may, for example, be obtainedfor each hourly or half hourly interval of the extended period.Preferably within each 24 hour period there is a single extended periodwhere a single representative temperature value is obtained for eachextended period.

Representative temperature values may, for example, be obtained by anyof the following steps:

-   -   Calculating the mean of the non-disregarded temperature readings        collected during the complete extended period or collected        during a specific time interval of the extended period (if more        than one representative value is to be obtained for each        extended period).    -   Calculating the median of the non-disregarded temperature        readings collected during the complete extended period or        collected during a specific time interval of the extended period        (if more than one representative value is to be obtained for        each extended period).    -   Calculating the mode (most commonly occurring temperature        reading) from the data collected during the complete extended        period or collected during a specific time interval of the        extended period (if more than one representative value is        obtained for each extended period).    -   Choosing the temperature reading or readings at a particular        distance in time from the start or the end of a stretch of        non-disregarded temperature readings. For example, the        representative value may be chosen as the temperature reading        taken half way through the stretch of non-disregarded        temperature readings. Alternatively representative values may be        chosen as the temperature readings taken at regular intervals        during a stretch of non-disregarded temperature readings, for        example, every hour or every half hour.    -   By the use of deviations of single measurement points from a        representative or from an idealised model of diurnal temperature        change, for example by calculating a standard deviation, a        variance or higher moments.    -   Calculating a derivative or integral of the temperature readings        over time collected during the complete extended period or        collected during a specific time interval of the extended period        (if more than one representative value is to be obtained for        each extended period). For example, the slope representing the        rate of change of temperature.

According to certain preferred embodiments, all temperature readingsthat remain after those having one or more characteristics of faulty orirrelevant data are disregarded are used as representative temperaturevalues.

It has been unexpectedly discovered by the Inventors that contrary tothe teaching of DE3342251 which suggests that maximum or minimumtemperature readings for each extended period make good representativetemperature values, it is preferable to obtain a representativetemperature value that is not influenced, or not significantlyinfluenced, by the maximum or minimum readings for extended period.Examples of such values include the “trimmed mean” of the temperaturereadings. To obtain such a trimmed mean one disregards a pre-determinednumber of the lowest and a pre-determined number of the highest readingsobtained during an extended period and calculates the mean of thosereadings that remain. Median and mid-percentile (for example 10^(th) to90^(th) or the 20^(th) to 80^(th) percentile or the 30^(th) to 70^(th)percentile values are also relatively immune to the effects of othertemperature readings and are preferred in accordance with certainembodiments of the invention.

A further surprising discovery of the Inventors is that irrelevanttemperature readings are more likely to come about because of heating ofthe female subject than by cooling of the subject (i.e., a woman'stemperature during an overnight (asleep) extended period is more likelyto deviate from her true basal body temperature in an upward rather thandownward direction). That is to say, a woman is more likely toexperience a temporary and irrelevant temperature rise than she is atemporary and irrelevant temperature fall. The reason for this is notfully understood but it is reliably observable in most women and istherefore assumed to be a factor of an underlying and universalphysiological phenomenon.

This observation means that a better representative temperature valuemay be obtained for an extended period by use of an algorithm that givesgreater statistical weighting to temperature readings that are lowerthan the median temperature reading than is given to the temperaturereadings that are higher than the median temperature readings (whilst,of course, at the same time giving little weight to the minimumtemperature reading and those readings near to the maximum temperaturereading).

It has been found that the 25^(th) percentile of non-disregardedtemperature reading makes an especially good representative temperaturevalue for an extended period. Other readings near to the 25^(th)percentile of non-disregarded temperature readings will also serve well.

According to certain preferred embodiments the representativetemperature value for an extended period is the 10^(th) to 60^(th)percentile value of the non-disregarded temperature readings. Morepreferably it is the 11^(th) to 50^(th) percentile value, morepreferably the 12^(th) to 40^(th) percentile value, more preferably the13^(th) to 46^(th) percentile value, more preferably the 14^(th) to44^(th) percentile value, more preferably the 14^(th) to 42^(nd)percentile value, more preferably the 15^(th) to 40^(th) percentilevalue, more preferably the 16^(th) to 38^(th) percentile value, morepreferably the 17^(th) to 37^(th) percentile value, more preferably the18^(th) to 35^(th) percentile value, more preferably the 19^(th) to33^(rd) percentile value, more preferably the 20^(th) to 31^(st)percentile value, more preferably the 21^(st) to 29^(th) percentilevalue, more preferably the 22^(nd) to 28^(th) percentile value, morepreferably the 23^(rd) to 27^(th) percentile value, more preferably the24^(th) to 26^(th) percentile value. Most preferably it is the 25^(th)percentile value.

Step ii and iii of the Method Carried Out Together

It will be appreciated that under some circumstances the temperaturereadings may be subjected to processing which will result in both thedisregarding of faulty and irrelevant data and the obtaining of arepresentative temperature value. In those circumstances one may regardsteps ii and iii of the method of the invention as taking placesimultaneously. For example, if one were to take the raw temperaturereadings of an extended time period and calculate a trimmed mean onewould be disregarding outlying temperature readings (likely to be faultyor irrelevant data) and obtaining a representative temperature value ina single step. Although both steps may take place simultaneously itshould be appreciated that both ii), identifying and disregardingtemperature readings having one or more characteristics of faulty orirrelevant data, and iii), obtaining one or several representativetemperature values for the extended period, need to take place inaccordance with a method of the invention.

Repeating Over Multiple Extended Periods

The steps of taking multiple temperature readings over an extendedperiod, disregarding temperature readings having the characteristics offaulty or irrelevant data and obtaining one or several representativetemperature values for each extended period, are repeated over multipleextended periods.

Preferably said steps are repeated over at least 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 or 26extended periods (in general the larger number of extended period themore preferred). Most preferably said steps are repeated over multipleextended periods covering several days (preferably with one extendedperiod each day).

Preferably said steps are repeated over at least one full ovulatorycycle, more preferably over several cycles.

Preferably said steps are repeated over a sufficient number of extendedperiods such that said extended periods would be expected to extend overa time period sufficient for one (or preferably more than one) ovulatorycycle to take place in an archetypical fertile female mammal of thespecies of interest regardless of the fact that the individual femalemammal from which the temperature readings are taken may or may not haveovulatory cycles. Preferably said steps are repeated over a sufficientnumber of extended periods such that there is at least one extendedperiod in most of the days of an ovulatory cycle. For reasons of comfortand hygiene it is not appropriate for an intravaginal indwelling deviceto be worn during days of menstruation. In such circumstances it ispreferable for there to be at least one extended period (preferably asingle extended period) corresponding to each and every day of theovulatory cycle in which menstruation does not take place.

Analysis of Representative Temperature Values

The fifth step of the method comprises analysing the representativetemperature values obtained over multiple extended periods for one ormore patterns in the representative temperature values indicative orpredictive of ovulation. By “analysis for one or more patternsindicative or predictive of ovulation”, it is meant that the analysis issuch that should ovulation have taken place or be imminent, the analysiswill identify one or more patterns indicative or predictive ofovulation. If ovulation has not taken place and is not imminent suchpatterns will not be identified.

According to certain embodiments, it is preferred that the multipleextended periods for which representative temperature values areanalysed comprise at least 3 extended periods, more preferably at least5 extended periods, more preferably at least 7 extended periods, morepreferably at least 9 extended periods, more preferably at least 12extended periods, more preferably at least 14 extended periods, morepreferably at least 16 extended periods, more preferably at least 18extended periods, more preferably at least 20 extended periods, morepreferably at least 22 extended periods, more preferably at least 24extended periods, more preferably at least 26 extended periods, mostpreferably 28 or more extended periods.

According to certain preferred embodiments wherein each extended periodcorresponds to an overnight period during which temperature readings aretaken, the multiple extended periods for which the representativetemperature values are analysed correspond to and equal in number all ofthe days of a complete cycle minus the days during which menstruationtakes place.

Preferably said multiple extended periods comprise those collected overat least one, preferably several ovulatory cycles. According to certainpreferred embodiments said multiple extended periods extend over everyday of one or more ovulatory cycles with the exception of those days inwhich menstruation takes place, when useful temperature data is unlikelyto be collected and the use of an indwelling temperature recordingdevice may be undesirable for reasons of comfort and hygiene.

According to certain preferred embodiments said analysis occurs in realtime, that is to say, as soon as temperature readings are obtained foran extended period, one or more representative temperature values areobtained and are subjected to analysis in comparison with previouslyobtained representative values so that any outcome of the analysis maybe signalled in the next step of the method without necessarilyrequiring all of the representative values to necessarily have beenobtained.

However, according to other preferred embodiments the temperaturereadings are collected for a whole menstrual cycle (or for a wholemenstrual cycle with the exception of days wherein the obtaining oftemperature readings either by accident or intention did not take place)and stored. On completion of that cycle (signalled by the onset ofmenses) the temperature readings processed to give representative valuesand analysis of the cycle that has just finished is undertaken.

Analysis of the representative temperature values involves theidentification of a pattern in the representative temperature valuesindicative or predictive of ovulation only if such a pattern is presentin the representative temperature values. In an anovulatory woman,analysis will involve seeking but not finding such patterns.

Patterns in representative temperature values indicative or predictiveof ovulation include the peak in body temperature associated with the LHpeak which occurs just before ovulation and the earlier temperature dipassociated with the rise in oestradiol.

Because the temperature dip associated with the rise in oestradioloccurs earlier and the period of peak fertility in humans is severaldays before ovulation, it is preferred that the method of the inventiondetects the oestradiol-associated temperature dip. The Applicant is notaware of any prior art removable device that is able to accuratelydetect this temperature dip because its magnitude is small. The deviceof the present invention in its preferred embodiments is able toreliably detect the oestradiol-associated temperature dip because of itshigh accuracy in temperature measurement and innovative data processing(for example the disregarding of faulty and irrelevant data).

For example, methods of pattern identification which may be used arealready described in the literature. See for example McCarthy et al(1983) A comparison of methods to interpret the basal body temperaturegraph. Fertility Sterility 41 640-646. For example the “three over six”method in which ovulation is indicated when three consecutiverepresentative temperature values are registered, all of which are abovethe average of the representative temperature values of the last sixpreceding days. Ovulation is deemed to have occurred on the daypreceding the first day of the 3 consecutive days showing elevatedrepresentative temperature values. According to the usual application ofthis rule a single day corresponds to a single representativetemperature value.

Similar, but more sophisticated methods may also be employed. These areessentially, as are the above methods, based on statistical qualitycontrol and process control methods and these are described in, forexample, Ryan, T. P. (1989) Statistical Methods for Quality ImprovementJohn Wiley & Sons, New York; Wetherill, G. B. and Brown, D. W. (1991)Statistical Process Control. Chapman and Hall, New York.

For many women the “3 over 6” rule gives a satisfactorily robustdetermination of the day of ovulation.

However, it has a drawback in that it requires temperature values tohave been obtained on each of the 6 days prior to ovulation. This maynot have been achieved in practice because of a very short or irregularcycle or because of obtaining temperature readings in all 6 days mayhave been missed.

It is therefore proposed to use in certain preferred embodiments analternative to the “3 over 6” rule which can either be used in place ofthe “3 over 6” rule or as a fall-back analysis method for use when the“3 over 6 rule” fails to detect on ovulation. Again according to theusual application of this rule, a single representative temperaturevalue is obtained per day.

According to this alternative rule the mean of at least threeconsecutive representative temperature values is obtained and comparedwith the following 3 representative consecutive representativetemperature values. If the following 3 consecutive temperature valuesare higher than the mean, ovulation is deemed to have taken place on thecorresponding to the first representative temperature value. If not, theanalysis is repeated but this time the mean is obtained from 4consecutive representative temperature values. If ovulation is notdetected the analysis is repeated again but this time the mean isobtained from 5 consecutive temperature values, then from 6, 7, 8, 9,10, etc until ovulation is detected or the end of the cycle is reached.

In either the “3 over 6” rule or the improved version described above inorder for ovulation to be deemed to have occurred the 3 consecutiverepresentative temperature values should be higher than the mean (eitherthe mean of the 6 proceeding values as in the “3 over 6” rule or the“cumulative mean” in the improved rule described above) by more than apre-set threshold amount. That threshold amount should be set at a valuewhich provides for reliable detection of genuine ovulations with theminimum of false positives. Preferably the threshold value is from 0.08to 0.25° C., more preferably from 0.09 to 0.24° C., more preferably from0.10 to 0.23° C., more preferably from 0.11 to 0.22° C., more preferablyfrom 0.12 to 0.21° C., more preferably from 0.13 to 0.20° C., morepreferably from 0.14 to 0.18° C., more preferably from 0.15 to 0.17° C.,more preferably from 0.16 to 0.17° C., most preferably 0.1667° C. If,according to this method, more than one apparent ovulation is detected,further analysis may be used to decide which apparent ovulation is mostlikely to correspond to the true ovulation. Either the analysis of therepresentative temperature value may be repeated with an incrementallyincreased pre-set threshold value (as explained above) until only asingle apparent ovulation event is detected, or the timing of themultiple apparent ovulation events is considered and the event occurringnearest to the expected day of ovulation (calculated from data obtainedfrom prior cycles—or if not available from population averages) ischosen as the day of true ovulation.

Preferably, the method used may be further enhanced by using historicaldata and a Bayesian approach to evaluation or to prediction. ‘Prior’(historical) data can be provided either from population data availablein the literature or from data available from previously recorded cyclesfor the individual female mammal or preferably from both population dataand from the individual female's previous cycle or cycles. For example,data such as the ‘corrected day-specific probabilities of clinicalpregnancy’ as provided in Dunson et al (2001). Assessing human fertilityusing several markers of ovulation. Statistics in Medicine 20 965-978can be used to enhance the evaluative or the predictive method in humanfemales. The ‘prior’ data are combined with the current data using aBayesian methodology to enhance evaluation or prediction.

Input of Supplementary Information by User

In addition to data deriving from the recorded temperature readings,according to certain embodiments the analysis of representativetemperature values may also involve the use of supplementary informationinputted by the user.

For example, the user may be required to identify the first day of hercycle (first day of menses) by pressing a button on the device or byentering the date prior to the analysis step of the method. Thatinformation may be used to identify cycle length and to place detectedovulation into the context of the full cycle.

Additionally it is known that fever caused by infection may affect basalbody temperature. The method of the invention therefore optionallyprovides the facility for such days to be tagged or otherwise beidentified by the user and excluded from subsequent analysis.

Dealing with Missing Data

On occasions, a representative temperature value may not have beenavailable for a particular extended period. This may be the case if notemperature readings have been obtained for that extended period or ifthe user has requested that the value for that extended period bediscounted (by, for example, identifying that extended period as havingtaken place during a period of fever).

Appropriate statistical methods may be used to minimise the impact ofmissing data.

For example, if the day of ovulation as detected by an elevated basalbody temperature is determined to take place on a day after a day forwhich data is missing, the ovulation may in fact have taken place oneither of the two days. The method of the invention may thereforeinclude the step of deciding on which day ovulation was most likely tohave taken place. This decision may involve deciding which day is mostlikely the day of ovulation by comparison with prior data from previouscycles (or such data is not available population average data).

Provision of Information to User

The final part of the method according to the invention comprisesproviding information relevant to the fertility of the female mammal toa user.

In its simplest form that information may be provided visually (i.e., bythe illumination of a lamp or LED or the display of graphicalinformation on an LCD). If the user is a female human the informationmay be provided directly to her. Alternatively or additionally, theinformation may be provided to a person responsible for the medical orveterinary supervision of the female animal. For example information maybe provided to a woman's physician or to a veterinary surgeon. Such aprovision of information may involve the electronic transmission of asignal, for example via the internet, via a wireless radio network (forexample an SMS or “text” message) or via a telephone line.

According to certain embodiments, the information may be supplied tomultiple people. If the method is used by a human couple in order toassist in timing intercourse so as to maximise the chance of conception,a signal indicating immediate or imminent fertility could be sent toboth partners by text message to enable them to plan their intercourse.

If the method is used as an aid to medical diagnosis it may not beappropriate to indicate the signal directly to the patient because ofthe possibility for misinterpretation (especially misinterpretation inthe absence of other medical results) and the causing of unnecessaryanxiety and distress. Instead the signal may be communicated to thepatient's physician for medical evaluation (typically involving thefactoring in of other information, for example the results of bloodtests) before a diagnosis is reached and communicated to the patient.

According to certain embodiments, the information need not be directlycommunicated to the user. Instead it may be sent electronically to adata store (for example a remote computer file server) where it may beretrieved at a later date either by the patient or by their medicalsupervisor.

According to certain embodiments, the information is immediatelycommunicated to a female human and a further signal is sent to thatfemale human's electronic medical records to be retrieved in the futureif and when required.

According to certain embodiments simplified information may be suppliedto the woman (for example the message “your cycle lengths are irregular,you should discuss this with your doctor”) and more detailed datasupplied to the woman's doctor (including under some circumstances rawtemperature readings or details of the representative temperature valuesfor each extended period).

According to certain preferred embodiments, the information communicatedto the user includes a predicted start date and predicted end date ofthe next “fertility window” (i.e., period during which insemination hasa relatively high chance of resulting in a pregnancy).

The method of the invention may be used for the detection of ovulationas an aid to diagnosis of subfertility or infertility, for example, bythe identification of patients in which ovulation is absent orirregularly timed. The diagnosis of a disorder of ovulation may allow anappropriate surgical or drug treatment to be offered and the success orotherwise of treatment aimed at bringing about ovulation can bemonitored. The method of the invention also assists in determining thebest timing for IUI (Intrauterine Insemination) or IVF (in vitrofertilisation).

Alternatively, detection of some types of subfertility may lead to therecommendation that further monitoring of ovulation take place accordingto the invention as an aid to conception.

Information relevant to the fertility of a female mammal provided by theremote computer file server to a user may include a specific alert thatone or more of the following events have taken place:

-   (1) Female about to enter a predicted fertile period.-   (2) Female has just ovulated (i.e. LH peak associated with    temperature rise detected).-   (3) Patient failed to ovulate within more than 1, more than 2, more    than 3, more than 4, more than 5, more than 6, more than 7, more    than 8, more than 9 or more than 10 days of predicted ovulation    date.-   (4) An anovulatory cycle completed.-   (5) Cycle more than 1, more than 2, more than 3, more than 4, more    than 5, more than 6, more than 7, more than 8, more than 9, or more    than 10 days different in length from previous cycle.-   (6) Monophasic cycle detected (i.e. no pre-ovulation LH peak    detected, possibly indicative of low oestrogen output).-   (7) An abnormal length of cycle. For example a cycle length outwith    the 2.5 and 97.5 percentiles expected for the species, ie more than    37 days or less than 20 days.-   (8) A post-ovulatory phase (ie number of days following detection of    ovulation to start of next cycle of less than 9 days).

If the user is a female woman for whom fertility information is beingprovided, the information provided may be limited to information aboutpredicted fertility at a future time (i.e. item 1 on the above list).Items 2 to 8 are useful for diagnostic purposes and so may more usefullybe provided to a user who is a physician responsible for the care of thefemale woman for whom fertility information is being provided. Items 3to 8 are events associated with infertility and sub-fertility. However,women with “normal” fertility may occasionally experience some of theseevents. It may therefore be appropriate to provide information to a userif events 3 to 8 occur a sufficient number of times to indicate afertility problem, for example, if they occur more than twice in anythree consecutive cycles.

Alternatively, the method of the invention may be used for the detectionof ovulation as an aid to the prediction of fertility at any particularinstant in time, such information being of use both as an aid toconception and as a method of contraception. In such circumstances itmay be preferable that the signal provided to the user is a simplebinary indication of “fertile” (ovulation detected or predicted asimminent) or “non-fertile” (ovulation not detected or imminent). Whenthe method is used as an aid to conception copulation (or artificialinsemination) can be timed to take place when a “fertile” indication isgiven. When the method is used as a form of contraception, unprotectedsex can take place when a “non-fertile” indication is given. A “fertile”indication informs the user to either abstain from sex or to use asupplementary form of contraception (for example a method of barriercontraception such as a condom).

Prediction of Fertile Period

The oestradiol-associated temperature dip precedes ovulation byapproximately 4 days. The detection of this dip may therefore be used toidentify the start of the “window of fertility”.

However, for methods based on the detection of temperature risesassociated with the LH-surge, the temperature rise is detected at theend of the “window of fertility”. The detection of the LH-surgetherefore comes too late to inform the user of the timing of thefertility window in the current cycle. It can, however, be used todetermine the day of ovulation which can be used to predict the windowof fertility in the next cycle.

According to such methods, the day of ovulation in the current cycle isdetermined. At the start of the next cycle the day of ovulation ispredicted based on the day of ovulation (i.e., the number of days sincethe start of the cycle) observed in previous cycles (for example the dayof ovulation may be estimated to take place on the median of the day ittook place on up to the 12 previous cycles). If information on theprevious days of ovulation is not known (which would be the case if theuser had only recently started to use the method), then populationaverage data may be used until better data is available.

Once a future day of ovulation is known, the “window of fertility” maybe calculated based on the assumption that it begins 5 days beforeovulation and ends 1 day after ovulation.

Use in Monitoring Methods of Assisted Conception

Several methods of assisted conception involve the administration ofdrugs that cause super-ovulation. Such methods carry a risk thatmultiple fertilisations will take place and multiple pregnancies result.In order to minimise that risk it is useful to know how many ova havebeen released during a particular ovulation event. The number of ovasubsequently released correlates with the magnitude of the pre-ovulatingoestradiol surge and therefore with the pre-ovulating temperature dip.

According to certain embodiments of the invention, the pre-ovulatingoestrodiol-associated temperature dip may be observed and its magnitudeanalysed to give an indication of the number of ova that may have beenreleased. If a large number of ova appear to have been released the riskof multiple pregnancies will be elevated and it may be decided toabandon attempted fertilisation (for example fertilisation by naturalmethods or by IUI) in the current cycle.

The invention also provides a device for providing information relevantto the fertility of a female mammal comprising:

-   -   A temperature measuring device for taking multiple body        temperature readings from the female mammal during multiple        extended periods;    -   A memory for storing said temperature readings;    -   a processor for identifying temperature readings having the        characteristics of irrelevant or faulty data and either deleting        said readings having the characteristics of faulty or irrelevant        data or labelling them to be subsequently disregarded; and for        obtaining one or several representative temperature values for        each extended period, and for analysing the representative        temperature values obtained over multiple extended periods for        one or more patterns in the representative temperature values        indicative or predictive of ovulation; and    -   a signalling device to provide information relevant to the        fertility of the female mammal to a user.

Particular features identified as optional or preferred in respect ofthe foregoing description of the method of the invention (for exampledetails of the signalling device, the information, the extended periods,the recordal of temperature readings, the characteristics of faulty orirrelevant data, the representative temperature values, the analysis ofrepresentative temperature values and the patterns indicative orpredictive of ovulation) are also optional or preferred in respect ofthe device of the invention.

The temperature measuring device is preferably an indwelling devicewhich is preferably introduced into the vagina of the female mammal andleft to dwell for a period of time, for example a week, a month or anovernight period or for several days or for an entire menstrual cycle(preferable with the exception of the time of menstruation), and torecord the temperature of the female mammal at regular intervals overthat period.

When used in the human female the device is preferably smoothly shapedfor hygiene and comfort and similarly sized and shaped to a tampon. Asuitable cord may be attached to the device for ease of retrieval.

The device for indicating or predicting ovulation in a female mammalaccording to the invention also comprises a signalling device. Althoughthe signalling device may be provided in the same indwelling unit as thetemperature measuring device it is preferably housed in a separate unit(preferably a tabletop or bedside unit).

Communication between two units may require one unit to be electricallyplugged into the other. Preferably this is avoided. Communication may beby a wireless radio link. Most preferably communication between the twounits will be achieved by placing the indwelling unit onto or very closeto the tabletop unit so that communication may take place via the mutualproximity of induction coils in each unit.

If the indwelling unit is to be left in the female mammal overnight, itis preferably to be placed on the tabletop unit during the day. Thetabletop unit may be suitable shaped to retain the indwelling unitplaced onto it. For example, the table top unit may comprise a recess toreceive the indwelling unit.

Features may be provided on the indwelling unit to assist itsorientation on the table top unit. For example, shape-features and/orvisual markings may be provided to ensure that the relative alignment ofinduction coils is such that communication between the two units may beoptimised.

The indwelling unit is preferably battery (for example, rechargeablebattery) powered. The tabletop unit may also be battery powered but mayconveniently be powered by mains electricity. According to a preferredembodiment, the two units communicate via proximal induction coils. Saidcoils may also be used to recharge the battery in the indwelling unitfrom the mains power provided to the desk top unit. According to certainpreferred embodiments the tabletop unit is powered by a rechargeablebattery. This allows it to be kept in the bathroom where mains power isgenerally not permitted. The unit can be recharged in another part ofthe house during days of menstruation when the product is not in use.

According to certain embodiments the indwelling unit may be disposableafter a period of use (for example after use for a set number of cyclesor for a set number of days (for example 120 or 150 days).

The device according to the invention comprises memory for storing thetemperature readings.

In the two unit arrangement described above the memory may be providedin either unit. Preferably, the indwelling unit has sufficient memory tostore the temperature readings made during an extended period. Thisstored data is transmitted to the tabletop unit which also has a memoryto review said data.

According to alternative embodiments the indwelling unit does notcomprise memory and temperature readings are transmitted to the otherunit as soon as they are taken (for example by radio waves).

According to certain embodiments the indwelling unit comprisessufficient memory to record the temperature readings for a completecycle (or for several cycles). The readings need not be transmitted tothe table top unit until the end of the cycle.

The device according to the invention comprises a processor. In the twounit arrangement described above the processor is preferably placed inthe tabletop unit.

The device according to the invention also comprises a signallingdevice. In the simplest form this device may be a light (for example anLED). In the two unit arrangement described above, the signalling deviceis preferably provided on the tabletop unit. According to certainpreferred embodiments, the signalling device is a LCD display providedon the tabletop unit.

According to certain preferred embodiments, the signalling deviceprovides information to a female human which includes the predictedstart and end times of her next window of fertility. She may also beprovided with a simplified summary of her likely fertility and messagesrecommending visits to her physician when appropriate.

The signalling device may, in the case of a device for use by a femalehuman, provide information to the female human. Alternatively, oradditionally the signalling device may provide a signal to the female'sphysician or to another person.

Whilst the method of the invention may be carried out by the device ofthe invention, it is also provided that the temperature readings and/orthe representative temperature values may be sent to a remote processingdevice for analysis. The result of the analysis may then be sent back tothe user in the form of information about fertility of the female mammalor stored on a computer server for access by authorized andauthenticated users, which may include the female and/or her medicalsupervisor(s).

According to certain preferred embodiments there is provided a methodaccording to the invention wherein one or more of steps:

-   -   ii) identifying and disregarding temperature readings having one        or more characteristics of faulty or irrelevant data;    -   iii) obtaining one or several representative temperature values        for the extended period;    -   v) analysing the representative temperature values obtained over        multiple extended periods for one or more patterns in the        representative temperature values indicative or predictive of        ovulation in order to provide information relevant to the        fertility of the female mammal to a user        are carried out by a remote data processing device.

By remote data processing device it is meant a device remote to the userto which the temperature readings and/or representative temperaturevalues are transmitted by telephony, wireless telephony or by use of aninternet protocol.

An advantage of carrying out one or more of steps ii), iii) and v) at aremote data processing device is that the remote data processing devicecan be shared by multiple users and therefore greater processing powercan be provided more cost effectively. Also, software and hardwareimprovements or upgrades can be provided more conveniently to a centraldata processing device than to devices located with individual users.

A further advantage of sending the temperature readings and/ortemperature values to the remote data processing device is that greatermemory capacity can be provided so that the readings or values from oneextended period can be more conveniently stored and used in the analysisof representative temperature values obtained from future extendedperiods. The storage of such data permits a historical picture of thefemale mammal's temperature readings during a number of previousovulatory cycles to be built up. That data can be compared with newlyobtained data in order to improve the accuracy of the analysis of thenewly obtained data.

If the remote data processing device is arranged to be shared bymultiple users, it will be sent temperature readings and representativetemperature values from multiple users. That data may be stored.Analysis of the representative temperature values obtained from a singlefemale mammal may be analysed by comparing them with the values obtainedfrom other female mammals or by comparing them with derivative data (forexample, average data) obtained from other female mammals.

It is known that in humans there is significant variation in theirovulatory cycles between women. By compiling an ever-expanding databaseof temperature values from multiple women, it will be possible todetermine what values may be regarded as normal and what values may beregarded as abnormal. The identification of abnormal values may be asign of sub-fertility or infertility and therefore an aid to diagnosisof sub-fertility or infertility.

It will be appreciated that there are privacy and data protectionconcerns raised by the transmittal of medical data to remote dataprocessing devices and by the storage of such data.

It is proposed to address those concerns by allocating unique identifiercode to each female mammal. That code will be preferably incorporatedinto the equipment provided for use by the female mammal. Temperaturereadings and/or representative temperature values sent to the remotedata processing device will be anonymous in that they will not beaccompanied by any meaningful identifier of the female (for examplename). The unique identifier code means that the female can only beidentified by someone who knows which code has been allocated to whichfemale. It may be convenient for the unique code to be both incorporatedinto the equipment and provided to the female user and/or her physician(for example by being provided on the equipment packaging or in theinstruction manual).

The results of the analysis (i.e., the information relevant to thefertility of the female mammal) may be stored on a remote computerserver. The female and/or her physician will be the only people who willknow her unique identification code. They will be able to use that codeto retrieve the data for that female only. Even if they (or someoneelse) were able to access the data for other women, the privacy of thoseother women would not be compromised because without knowing the uniqueidentification code for the other women, such data would remaineffectively anonymous.

In accordance with certain embodiments of the method of the inventionthere is provided between step i) and step ii) a further step ia), orbetween step ii) and step iii) a further step iia), or between step iii)and step iv) a further step iiia).

Said further step ia) comprises labelling the temperature readings witha unique identifier and transmitting them to a remote data processingdevice, wherein said steps ii) iii) iv) and v) are carried out by theremote data processing device.

Said further step iia) comprises labelling the temperature readings witha unique identifier code and transmitting them to a remote dataprocessing device, wherein said steps iii), iv) and v) are carried outby the remote data processing device.

Said further step iiia) comprises labelling the representativetemperature values with a unique identifier code and transmitting themto a remote data processing device, wherein said steps iv) and v) arecarried out by the remote data processing device.

Steps carried out prior to step ia) step iia) or step iiia) are carriedout by the user's terminal.

According to certain preferred embodiments, the method of the inventioncomprises a further step vi) after step v).

Said step vi) comprises either:

a) transmitting said information relevant to the fertility of the femalemammal to the user's terminal

or

b) storing said information about fertility of the female mammal on acomputer server for retrieval by the user's terminal and; optionally byone or more further nominated terminals in possession of the uniqueidentifier code.

In order to carry out certain embodiments of the method of theinvention, the invention also provides a user terminal comprising:

-   -   a temperature measuring device for taking multiple body        temperature readings from a female mammal during multiple        extended periods;    -   a memory for storing said temperature readings;    -   means for communicating the multiple body temperature readings,        or a derivative thereof, stored in the memory to a remote data        processing device;    -   means for receiving information relevant to the fertility of the        female mammal from a remote computer file server;    -   a signalling device to provide said information relevant to the        fertility of the female mammal to a user.

The temperature measuring device, the memory and the signalling device,and their arrangement in one or more units is preferable as described inrespect of the device of the invention.

The invention also provides a remote data processing device comprising:

-   -   means for receiving multiple body temperature readings of a        female animal or a derivative thereof from a user;    -   a processor for identifying temperature readings having one or        more characteristics of irrelevant or faulty data and either        deleting said readings or labelling them to be subsequently        disregarded; and for obtaining one or several representative        temperature values for each extended period; and for analysing        the representative temperature values obtained over multiple        extended periods for one or more patterns in the representative        temperature values indicative or predictive of ovulation and        thereby provide information about fertility of the female mammal        to a computer file server for later retrieval by a user.

The multiple body temperature readings, the one or more characteristicsof irrelevant or faulty data, the methods of obtaining one or severalrepresentative temperature values for each extended period; and foranalysing the representative temperature values are preferably asdescribed above in reference to the method of the invention.

The invention also provides a remote computer file server holdinginformation about fertility of multiple female mammals, the informationrelating to each female mammal being labelled with a unique identifiercode corresponding to an individual female mammal, said file serverbeing arranged to provide to a user, the information labelled with aparticular unique identifier code in response to the provision of thatcode to the remote computer file server.

According to certain preferred embodiments the remote computer fileserver is receiving data from a number of female humans who are patientsof a specialist fertility physician.

Preferably, the computer file server provides long-term storage ofinformation about fertility of each woman.

Such an arrangement will permit the physician responsible for the careof the woman, and in possession of that woman's unique identifier code,to call up the woman's historical data in numerical and graphical formfor review as an aid to diagnosis and/or treatment.

Preferably, the physician is provided with appropriate software toenable said physician to view the data retrieved from the server.

According to certain preferred embodiments, the physician's computer isprovided with software that automatically polls the central computerfile server, identifies itself and its list of patients, and downloadstheir data. It then displays to the physician a “highlights list” whenshe logs on in the morning. Said “highlights list” highlights to thephysician information from patients for whom a significant event (forexample ovulation) has taken place and or from patients whereintervention of the physician may be required.

According to certain preferred embodiments, the remote computer fileserver provides the information on a world wide web page or in the formof e-mails. Such an arrangement removes the need for the physician tohave specialist software to view the data retrieved from the serverbecause it could be viewed using a standard web browser or e-mail clientsoftware.

The following non-limiting examples illustrate the invention. It isunderstood that specific technical features disclosed in the context ofan example may be generally applied to the invention as a whole:

Example 1

FIG. 1 illustrates diagrammatically an apparatus and method inaccordance with a certain preferred embodiment of the invention. It isto be understood that features disclosed in respect of this preferredembodiment may be applied to other embodiments of the invention.

There is provided to a female human a user terminal 1 comprising atemperature measuring device provided in an indwelling unit 2. Theindwelling unit 2 is designed for intravaginal use and is smoothlyshaped for comfort and hygiene. It is provided with a cord 3 for ease ofretrieval. The indwelling device is used worn in the vagina every nightfrom the first night following the end of menstruation until such timeas the next menstrual period starts. The indwelling unit comprises anelectronic temperature measuring means which takes multiple temperaturereadings at regular time intervals during the overnight period. Theindwelling unit is powered by battery and comprises a memory unit whichrecords the temperature readings taken during the overnight period. Theindwelling unit is waterproof and sealed and therefore is eitherdisposed of when the battery is flat or else is provided with arechargeable battery and associated circuitry so that it may berecharged.

When the woman wakes up, she removes the indwelling unit and washes itin the bathroom, for example by rinsing under a running tap. During theday whilst the woman is awake and active, the indwelling unit is placedonto a tabletop unit 4 which is also provided to the woman and may beconveniently positioned in the bathroom. The tabletop unit isconveniently provided with a recess 5 in its upper surface which isshaped to retain the indwelling unit placed onto it. Both the indwellingunit and the tabletop unit are provided with induction coils which arearranged so that when the indwelling unit is placed in the recess of thetabletop unit the induction coils come into mutual proximity so that thetwo units may communicate (illustrated by arrow 6). During the day, thetemperature readings stored in the memory of the indwelling unit aretransferred to a memory in the tabletop unit. If the indwelling unit isprovided with a rechargeable battery, the battery may be recharged bythe transfer of electrical energy through the induction coils. At theend of the day the woman removes the indwelling unit from the recess andplaces it in her vagina so that it may record her body temperatures overthe following night.

The indwelling unit is arranged so that it only records temperaturereadings during an overnight period. Various methods may be employed toensure that. In one preferred method the indwelling unit willincorporate a clock and will be programmed to record temperature onlyduring a time period when it is expected that the woman would be asleep.In another preferred embodiment, the woman is instructed that with theexception of brief periods of cleaning after removal and beforeinsertion, the device is to be placed in the recess of the tabletop unitat all times when it is not in the vagina. In such an embodiment theindwelling unit will be arranged to sense whether it is in the recessand programmed to take temperature readings only when it is not in closeproximity to the table top unit. It may also be programmed to not recordor to disregard temperature readings taken within a short time period(for example, 30 minutes) before and after being placed in the recess ofthe table top device. Such a short time period will likely containerroneous temperature readings caused by the indwelling unit beingwashed or by the thermal lag time when it is first inserted and needs towarm up to body temperature. According to another embodiment, the tabletop unit is provided with user operated buttons (7, 8) which can be usedby the woman to instruct the device that she is about to insert thedevice or that she has just removed the device.

According to certain preferred embodiments the woman is instructed topress a button (either on the indwelling unit or more preferably on thetable top unit) to register when she is about to place the indwellingunit and go to bed. Additional input buttons may be provided, forexample, for the woman to enter “fever days” to be discounted fromcalculation or for the woman to signal the start of her cycle (ie thefirst day of menstruation).

When the table top unit 4 has acquired the temperature readings takenthe previous night, those readings are automatically transmitted to aremote site (remote site illustrated by dotted line 9, transmission byarrow 10). Transmission may be by wireless telephony or via a telephoneline or via the internet or by any other convenient route for whichappropriate hardware (for example, modems) and software protocols areprovided. According to certain embodiments, transmission need not takeplace until the woman signals the end of her cycle. A whole cycle'sworth of readings may then be transmitted. According to suchembodiments, a button may be provided on one of the units (preferablythe table top unit) for a woman to signal the end of her cycle and alsoto start the transmission of data relating to the cycle just completed.

At the remote site there is provided a processor 11 for analysing thetemperature readings in accordance with the method of the invention, anda file server 12 for storing the temperature readings and the results ofthe analysis. The remote site may be in communication with multipletabletop units being used by different women. The readings from eachwoman are identified by being labelled by the appropriate desktop unitwith a unique identifier code.

Information about the fertility of the woman may be transmitted back tothat woman's tabletop unit and displayed on a display screen 13 providedon that unit, said information will also be stored, labelled with thewoman's unique identifier code, on the file server.

Information relevant to the fertility of the woman may also be accessedfrom the file server by other authorised users (represented by outputbox 14) in possession of the appropriate unique identifier code. Suchadditional users may include the woman's sexual partner and herphysician.

Example 2 Day and Night Temperature Readings

FIG. 2 shows temperature readings taken every five minutes using anintravaginal indwelling temperature measuring device from an individualwoman over two consecutive days (10 and 11 June). This 48 hour periodencompassed both day time periods when the woman was awake and activeand overnight periods when the woman was asleep—the bar at the bottom ofthe graph shows when the woman was awake and when she was asleep. It canbe seen from the graph that the overnight temperature readings when thewoman was asleep are subject to fewer fluctuations. This is because theyare subject to fewer irrelevant temperature changes. This data suggeststhat it may be preferable to obtain representative temperature valuesfrom temperature readings obtained during an overnight time period whenthe woman is asleep.

The conclusion drawn from FIG. 2 is reinforced by the data shown in thetable below which compares the standard deviation (SD) of temperaturereadings taken every 5 minutes both during the day and during anovernight time period when the subject was asleep. Data is presented fortwo different women (subject 1 and subject 2) over two 24-hour periodsfor each woman.

Subject SD of Day Readings SD of Sleeping Readings 1 0.266 0.112 1 0.4530.122 2 0.286 0.088 2 0.289 0.111

Example 3 Comparison of Alternative Representative Temperature Values

Lines A to E of FIG. 3 plot data derived from temperature readings takenevery 5 minutes from an indwelling temperature recording device(“personal sensor”) placed intravaginally in a woman from day 9 to day26 of her cycle.

In all cases the reading obtained during overnight periods was processedaccording to the invention to give a single representative temperaturevalue for each day of the cycle.

Line F plots a once-daily oral temperature reading.

The woman from whom the data was derived was of normal fertility and thecycle shown was an ovulatory cycle. One therefore would expect to seefirst a temperature slight dip and then a temperature rise as the cycleprocesses.

Line F shows that the oral temperature readings show a great deal offluctuation which is because of the influence of erroneous or irrelevantdata.

Lines A and E show less of such fluctuations and therefore demonstratethe advantages of taking multiple overnight temperature readings usingan indwelling device.

Lines A and E are plotted from representative temperature values thatare obtained, respectively, from the maximum and minimum temperaturereadings obtained during each extended period. It can be seen that incomparison to lines B to D, lines A and E show a high degree of unwantedfluctuations and therefore contrary to what is taught in DE 3342251, theuse of maximum and minimum temperature readings as representativetemperature values has drawbacks and is not to be preferred.

Lines B, C and D show, respectively, representative temperature valuesobtained from the median, mean and 25 percentile of the temperaturereadings in each extended period. It can be seen that the mean, medianand 25 percentile are all better representative temperature values overthe maximum and minimum, and that the 25 percentile (line D) is betterthan the other representative values plotted in the graph because itshows fewer fluctuations and corresponds most closely to the woman'strue core temperature.

Example 4

FIG. 4 shows temperature readings obtained from a woman during overnighttime periods spanning a single ovulatory cycle. Ovulation took place atday 16. The temperature readings plotted demonstrate that the method anddevice of the invention is sufficiently sensitive to detect not only theLH-associated temperature rise but also the pre-ovulatory temperaturedip which is associated with a rise in oestradiol levels.

The invention claimed is:
 1. A method of providing an indication relatedto the fertility of a female human comprising the steps of: (i) takingmultiple measured temperature readings from the female human during anextended overnight period using an intra-vaginal temperature measuringdevice; using a processor to process the measured temperature readingsto determine at least one representative temperature reading for theovernight period, the processing comprising the steps of: (ii)identifying and disregarding measured temperature readings having one ormore characteristics of irrelevant or faulty data to obtain a pluralityof non-disregarded temperature readings; (iii) processing the pluralityof non-disregarded temperature readings to obtain one or severalrepresentative temperature values for the extended period; (iv)repeating steps (i) to (iii) over multiple extended overnight periods;and (v) analysing the representative temperature values obtained overmultiple extended overnight periods for one or more patterns in therepresentative temperature values indicative or predictive of ovulationin order to provide information relating to the fertility of the femalehuman to a user, wherein the representative temperature values are notthe maximum or minimum temperature readings obtained for the extendedperiod, wherein said extended overnight period is one hour or longer,and providing intervention if said information provides an indication asto whether a significant event related to the fertility of the femalehuman has occurred.
 2. A method according to claim 1, wherein saidindication relating to the fertility of the female human is: a)information identifying the timing of ovulation, b) a binary indicationof “fertile” or “non-fertile”, c) an indication of the timing of thenext fertile period, d) an indication of normal fertility, subfertilityor infertility, or e) an indication of the number of ova releasedfollowing ovarian hyper-stimulation.
 3. A method according to claim 1,wherein said extended overnight period is of at least 4 hours.
 4. Amethod according to claim 1, wherein at least 25 temperature readingsare taken in said overnight extended period.
 5. A method according toclaim 1 wherein temperature readings are disregarded if they arecharacteristic of irrelevant or faulty data by reason of one of thefollowing: a) being more than 2° C. higher or lower than the normaltemperature of said female human, b) differing from the preceding orfollowing values by such a degree as to indicate heating or coolingrates of greater than 0.2° C. per minute, c) being a single reading orrelatively few readings that differ so much from the other temperaturereadings collected during the same extended period so as to be unlikelyto indicate a true change in temperature, d) being characteristic ofdiurnal temperature fluctuations unconnected to levels of femalehormones and therefore unrelated to ovulation, or e) being tagged assuch by user input.
 6. A method according to claim 1, wherein saidrepresentative temperature value(s) for the extended period is/areobtained by: a) calculating the mean of the non-disregarded temperaturereadings collected during the extended period or a part thereof, b)calculating the median of the non-disregarded temperature readingscollected during the extended period or a part thereof, c) calculatingthe mode of the data collected during the extended period or a partthereof, d) choosing the temperature reading or readings occurring at aparticular distance in time from the start or the end of a stretch ofnon-disregarded temperature readings, e) choosing all of the temperaturereadings remaining after those having one or more characteristics ofirrelevant or faulty data are disregarded, or f) choosing a singlerepresentative temperature value for each extended period that is the11^(th) to the 50^(th) percentile of the temperature readings obtainedfor that extended period.
 7. A method according to claim 1, wherein themultiple extended overnight periods for which representative temperaturevalues are analysed comprise those collected over at least one ovulatorycycle of the female human.
 8. A method according to claim 1, whereinsaid pattern indicative or predictive of ovulation is the peak in bodytemperature associated with the LH peak, or the dip in body temperatureassociated with a rise in oestradiol.
 9. A method according to claim 1,wherein said indication relating to the fertility of the female human isprovided to her or to her physician.
 10. A method as claimed in claim 1,wherein one or more of steps (ii), (iii) and (iv) are carried out by aremote data processing device.
 11. A method as claimed in claim 10,wherein between step (i) and step (ii) a further step (ia) is provided,said further step (ia) comprising labelling the measured temperaturereadings with a unique identifier and transmitting them to the remotedata processing device, wherein said steps (ii), (iii), (iv) and (v) arecarried out by the remote data processing device, or wherein betweenstep (ii) and step (iii) a further step (iia) is provided, said furtherstep (iia) comprising labelling the measured temperature readings with aunique identifier code and transmitting them to the remote dataprocessing device, wherein said steps (iii), (iv) and (v) are carriedout by the remote data processing device, or wherein between step (iii)and step (iv) a further step (iiia) is provided, said further step(iiia) comprising labelling the representative temperature values with aunique identifier code and transmitting them to the remote dataprocessing device, wherein said steps (iv) and (v) are carried out bythe remote data processing device, or wherein after step (v) therefollows a further step (vi) comprising either: (a) transmitting saidinformation about fertility of the female human to the user's terminal;or (b) storing said information about fertility of the female human on acomputer server for retrieval by the user's terminal; and optionally byone or more further nominated terminals in possession of the uniqueidentifier code.
 12. The method of claim 1 further comprising using theindication relating to fertility as: aid to diagnosis of anovulation, anaid to diagnosis of irregular ovulation, an aid to conception, acontraceptive method or an indication of the number of ova releasedfollowing hyper-stimulation of the ovary.
 13. The method of claim 1wherein said intra-vaginal temperature measuring device is removed fromthe female human during the day.
 14. A device for providing anindication related to the fertility of a female human, comprising: anintra-vagina temperature measuring device for taking multiple measuredtemperature readings from the female human during multiple extendedovernight periods; a non-transitory memory for storing said temperaturereadings; a processor for processing the measured temperature readingsto determine at least one representative temperature reading for theovernight period, wherein the processor is configured to process themeasured temperature readings to identify measured temperature readingshaving one or more characteristics of irrelevant or faulty data andeither delete said readings or label them to be subsequently disregardedto obtain a plurality of non-disregarded temperature readings; andwherein the processor is configured to calculate using the plurality ofnon-disregarded temperature readings one or several representativetemperature values for each extended overnight period; and wherein theprocessor is configured to analyse the representative temperature valuesobtained over multiple extended overnight periods for one or morepatterns in the representative temperature values indicative orpredicative of ovulation; and a signalling device to provide anindication related to the fertility of the female human to the user,wherein the representative temperature values are not the maximum orminimum temperature readings obtained for the extended overnight period,wherein said extended overnight period is one hour or longer, andprovide intervention if said indication indicates whether a significantevent related to the fertility of the female human has occurred.
 15. Adevice as claimed in claim 14, wherein said signaling device isconfigured to provide information relating to the fertility of thefemale human, the information comprising: a) information identifying thetiming of ovulation, b) a binary indication of “fertile” or“non-fertile”, c) an indication of the timing of the next fertileperiod, d) an indication of normal fertility, subfertility orinfertility, or e) an indication of the number of ova released followingovarian hyper-stimulation.
 16. A device as in claim 14 wherein saidextended overnight period is at least 4 hours and wherein theintra-vaginal temperature measuring device is configured to take atleast 25 temperature readings in said extended overnight period.
 17. Adevice as in claim 14 wherein said processor is configured to processthe measured temperature readings to identify measured temperaturereadings having one or more characteristics of irrelevant or faulty datacomprising: a) being more than 2° C. higher or lower than the normaltemperature of said female human, b) differing from the preceding orfollowing values by such a degree as to indicate heating or coolingrates of greater than 0.2° C. per minute, c) being a single reading orrelatively few readings that differ so much from the other temperaturereadings collected during the same extended period so as to be unlikelyto indicate a true change in temperature, d) being characteristic ofdiurnal temperature fluctuations unconnected to levels of femalehormones and therefore unrelated to ovulation, or e) being tagged assuch by user input.
 18. A device as in claim 14 wherein saidrepresentative temperature value(s) for the extended period is/areobtained by a processor further configured to: a) calculate the mean ofthe non-disregarded temperature readings collected during the extendedperiod or a part thereof, b) calculate the median of the non-disregardedtemperature readings collected during the extended period or a partthereof, c) calculate the mode (most commonly occurring temperaturereading) of the data collected during extended period or a part thereof,d) choose the temperature reading or readings occurring at a particulardistance in time from the start or the end of a stretch ofnon-disregarded temperature readings; e) choose all of the temperaturereadings remaining after those having one or more characteristics ofirrelevant or faulty data are disregarded, or f) choose a singlerepresentative temperature value for each extended period that is the11th to the 50th percentile of the temperature readings obtained forthat extended period.
 19. A device as in claim 14 wherein the processoris configured to analyse the representative temperature values toidentify a pattern comprising a peak in body temperature associated withthe LH peak, or a dip in body temperature associated with a rise inoestradiol.
 20. An apparatus comprising: an indwelling temperaturemeasuring device suitable for intravaginal use for taking multiple bodytemperature readings from a female human during multiple extendedovernight periods; and a separate unit configured to accommodate theindwelling temperature measuring device, wherein the separate unitcomprises: a non-transitory memory for storing said temperaturereadings; an internet, telephonic, or wireless link arranged forcommunicating the multiple body temperature readings, or a derivativethereof, stored in the non-transitory memory to a data processingdevice; and an internet, telephonic, or wireless link for receivingindication relating to the fertility of the female human from a remotecomputer file server; and a signalling device to provide saidinformation relating to the fertility of the female human to a user,wherein said extended overnight period is one hour or longer.
 21. A dataprocessing device comprising: a processor configured to: receivemultiple measured body temperature having one or more characteristics ofirrelevant or faulty data and either deleting said readings or labellingthem to be subsequently disregarded, thereby obtaining a plurality ofnon-disregarded temperature readings; process the plurality ofnon-disregarded temperature readings to obtain one or severalrepresentative temperature values for each extended period; analyse therepresentative temperature values obtained over multiple extendedovernight periods in order to identify a pattern in the representativetemperature values indicative or predictive of ovulation; and provide,based on the analysis, an indication related to the fertility of thefemale human to a computer file server for later retrieval by a user;wherein the representative temperature values are not the maximum orminimum measured temperature readings obtained for the extended period;and wherein said extended overnight period is one hour or longer. 22.The device of claim 21, further comprising: a non-transitory memoryconfigured to store an indication related to the fertility of multiplefemale humans, the indication stored in the non-transitory memoryrelating to each female human being labelled with a unique identifiercode corresponding to an individual female human, wherein saidinformation relating to the fertility of the female human received onthe internet telephonic or wireless link comprises the indicationlabelled with a particular unique identifier code in response to theinternet, telephonic or wireless link communicating that code to thecomputer file server.
 23. A method of providing an indication relatingto the fertility of a female human comprising: taking a plurality ofmeasured temperature readings from the female human during an extendedperiod using an intra-vaginal temperature measuring device; using aprocessor to process the plurality of measured temperature readings todisregard measured temperature readings having one or morecharacteristics of irrelevant or faulty data and determine from thefiltered plurality of measured temperature readings at least onerepresentative temperature reading for the extended period; repeatingthe steps of taking readings and processing the readings for a pluralityof extended periods to obtain at least one representative temperaturereading for each extended period over several days; using a processor toanalyse the representative temperature readings based on stored data ofexpected patterns of variations in temperature related to ovulation inthe female human; and using a processor to output an indication relatingto the fertility of the female human based on the analysis, andproviding intervention if said indication indicates whether asignificant event related to the fertility of the female human hasoccurred.
 24. A system for providing information relating to thefertility of a female human comprising: an intra-vaginal temperaturemeasuring device for taking multiple body temperature readings from thefemale human during multiple overnight periods, the intra-vaginaltemperature measuring device further comprising a rechargeable powersupply; a base unit for receiving the intra-vaginal temperaturemeasuring device, the base unit comprising a charger for charging therechargeable power supply for the intra-vaginal temperature measuringdevice; and one or more processors for performing a method comprising:taking a plurality of measured temperature readings from the femalehuman during an extended overnight period using an intra-vaginaltemperature measuring device; processing the plurality of measuredtemperature readings to: disregard measured temperature readings havingone or more characteristics of irrelevant or faulty data; and determinefrom a plurality of measured temperature readings at least onerepresentative temperature reading for the extended overnight period;repeating the steps of taking readings and processing the readings for aplurality of extended overnight periods to obtain at least onerepresentative temperature reading for each extended overnight period;analysing the representative temperature readings to identify one ormore patterns indicative or predictive of ovulation in the female human;and outputting an indication relating to the fertility of the femalehuman based on the analysis, and providing intervention if saidindication indicates whether a significant event related to thefertility of the female human has occurred.